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FDA product code · Gastroenterology, Urology · Class 2

PKL: Hemostatic Metal Clip For The Gi Tract

PKL is FDA's product code for "Hemostatic Metal Clip For The Gi Tract": a Class 2 device classified under 21 CFR 876.4400, reviewed by the Gastroenterology, Urology panel. FDA flags it as an implant and life-sustaining or life-supporting.

510(k) review time for PKL

Across 47 510(k) clearances under PKL decided from 2018-01-01 to 2026-10-06, the median was 188 days from FDA receipt to decision. Half took between 108 and 251 days, and 80% were decided within 260 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, PKL, decisions 2018-01-01 to 2026-10-06 (n = 47)
Fastest27
25th percentile108
Median188
75th percentile251
80th percentile260
90th percentile271
Slowest411
Median days by decision year, PKL (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20181165
20201646
20222599
20241818
20251626
2026 (to 10-06, partial)2355

Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.

PKL in the public FDA record

Records naming PKL, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years64
Establishment listings125
GUDID device identifiers985

Counts of records, not of devices or events. Adverse event reports for PKL are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.

FDA-recognized standards that cite PKL

No FDA recognized consensus standard cites PKL by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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